HEAVY-DUTY BACK TABLE COVER, 60 IN. X 90 IN. / 152 CM X 229 CM 42307NS 104230700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-26 for HEAVY-DUTY BACK TABLE COVER, 60 IN. X 90 IN. / 152 CM X 229 CM 42307NS 104230700 manufactured by O&m Halyard, Inc..

MAUDE Entry Details

Report Number3005997949-2019-00015
MDR Report Key8930115
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-08-26
Date of Report2019-10-03
Date of Event2019-07-02
Date Mfgr Received2019-10-03
Device Manufacturer Date2019-05-08
Date Added to Maude2019-08-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKEISHA WEAVER
Manufacturer Street5405 WINDWARD PARKWARY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4702804383
Manufacturer G1AVENT SA DE R.L. DE C.V. (AVENT 3)
Manufacturer StreetAV. HIDALGO NO. 6 ESQ. BLVD. LUIS DONALDO COLOSIO
Manufacturer CityNOGALES, 84093
Manufacturer CountryMX
Manufacturer Postal Code84093
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEAVY-DUTY BACK TABLE COVER, 60 IN. X 90 IN. / 152 CM X 229 CM
Generic NameEQUIPMENT COVERS
Product CodePUI
Date Received2019-08-26
Returned To Mfg2019-07-23
Model Number42307NS
Catalog Number104230700
Lot NumberAC9128122
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerO&M HALYARD, INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.